Senior Manager/Director Regulatory Affairs
Senior Manager/Director, Regulatory Affairs
San Francisco Bay Area (Hybrid/Onsite)
$175,000-$250,000
Job Description
EPM is partnered with a publicly traded commercial-stage medical device company that has developed a differentiated treatment for pulmonary and respiratory diseases and continues to expand its global footprint. The organization is seeking a Senior Manager or Director of Regulatory Affairs to play a key role in shaping regulatory strategy across a high-profile Class III product portfolio. This is an opportunity to join a collaborative leadership team where Regulatory Affairs has significant influence on product strategy, lifecycle management, and global expansion initiatives.
Key Qualifications
* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred.
* 8+ years of Regulatory Affairs experience within the medical device industry.
* Strong Class III and PMA experience required.
* Experience developing and executing regulatory strategies for complex medical devices.
* Prior experience with implantable, catheter-based, cardiovascular, structural heart, pulmonary, or other highly regulated medical device technologies preferred.
* Working knowledge of FDA regulations, guidance documents, and regulatory submissions.
* Experience collaborating cross-functionally with Quality, Clinical, R&D, and Marketing teams.
* Strong communication skills and ability to influence key stakeholders.
Roles & Responsibilities
* Lead regulatory strategy and execution for new product development, product changes, and lifecycle management activities.
* Author, review, and support PMA supplements, regulatory submissions, and agency interactions.
* Partner with cross-functional teams to assess regulatory risks and develop strategic pathways to support business objectives.
* Serve as a key regulatory advisor during product development and commercialization activities.
* Monitor evolving regulatory requirements and assess potential impact on products and business strategy.
* Support global regulatory initiatives, registrations, and market expansion efforts.
* Represent Regulatory Affairs during cross-functional decision-making and leadership discussions.
Benefits
* Competitive base salary and annual bonus opportunity
* Comprehensive medical, dental, and vision coverage
* 401(k) with company match
* Generous PTO and paid holidays
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